Hologic ThinPrep Operator's Manual page 22

Table 19: Laboratory Imager-Assisted Review Results vs. Laboratory Manual Review Results
for the Specimens with Reference Diagnosis of ASC-H+
In the study, there were 147 specimens with Reference Diagnosis of ASC-H+ (combined ASC-H, HSIL, and Cancer) and
1,090 specimens with Reference Diagnosis of (combined NILM, ASC-US/AGUS, and LSIL).
In this table, "Positive" means ASC-H+ or UNSAT, and "Negative" means NILM, ASC-US/AGUS, or LSIL. All
percentages are rounded to the nearest 0.1%.
ASC-H+
Imaged
Lab CT/
Pathologist
(95% CI)
93.7%
#1 (104/111)
(87.6% to 96.9%)
86.4%
#2
(127/147)
(79.9% to 91.0%)
95.2%
#3 (140/147)
(90.5% to 97.7%)
91.6%
Combined (371/405)
(88.5% to 93.9%)
Positive Percent Agreement
Manual
(95% CI)
88.3%
(98/111)
(81.0% to 93.0%) (-0.6% to 12.0%)
86.4%
(127/147)
(79.9% to 91.0%) (-6.8% to 6.8%)
89.8%
(132/147)
(83.8% to 93.7%) (-0.1% to 11.4%)
88.1%
(357/405)
(84.6% to 90.9%)
Difference Imaged
(95% CI) (95% CI)
5.4% 86.7%
(6/111) (615/709)
(84.0% to 89.0%)
0.0% 89.4%
(0/147) (974/1090)
(87.4% to 91.1%)
5.4% 88.2%
(8/147) (961/1090)
(86.1% to 90.0%)
3.5% 88.3%
(14/405) (2550/2889)
(0.0% to 7.0%) (87.0% to 89.4%)
Negative Percent Agreement
Manual
(95% CI)
86.7%
(615/709)
(84.0% to 89.0%)
89.4%
(975/1090)
(87.5% to 91.1%)
87.4%
(953/1090)
(85.3% to 89.3%)
88.0%
(2543/2889)
(86.8% to 89.2%)
MAN-03938-001 Rev. 002 page 18 of 23
Difference
(95% CI)
0.0%
(0/709)
(-2.2% to 2.2%)
-0.1%
(-1/1090)
(-1.8% to 1.6%)
0.7%
(8/1090)
(-1.0% to 2.5%)
0.2%
(7/2889)
(-0.8% to 1.3%)